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Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries

NCT06034834 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-20

No results posted yet for this study

Summary

To date, intraoperative assessment of tissue and bone viability is predominantly subjective, depending on the clinical view of the surgeon, resulting in a variation in the thoroughness of debridement. Inadequate initial resection leads to multiple debridement interventions, leading to prolonged hospitalization or readmission with consequently high direct medical costs.

Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) could potentially be a relevant contribution to adequately treating soft tissue and skeletal injuries by creating an improved distinction between viable and non-viable tissue, based on perfusion indices.

This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging is a feasible and quantifiable technique for treating traumatic injuries.

Conditions

  • Perfusion
  • Traumatic Injury
  • Fluorescence Imaging

Interventions

DIAGNOSTIC_TEST

Near-infrared fluorescence imaging of perfusion

Patients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging after clinical judgment and debridement of the traumatic injury. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure.

Sponsors & Collaborators

Principal Investigators

  • Stefan Koning, MD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2025-09-10
Completion
2025-11-10

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034834 on ClinicalTrials.gov